...
| Page properties |
|---|
1988 VERSION | Title | Brief Psychiatric Rating Scale 1988 Version (BPRS 1988 VERSION)
|
|---|
| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
|---|
| QRS Short Name | |
|---|
| QRS Permission Status | Public Domain |
|---|
| Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
|---|
| Supplement Version | 1.0 |
|---|
| Status | DRAFT |
|---|
| Date | 2020-0709-0723 |
|---|
| Notes | This supplement is intended to be used with other CDISC User Guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials. |
|---|
|
...
Revision History
| Date | Version |
|---|
2020-0709-0723
| 1.0 Draft |
© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
...
The scale points include a numeric rating (0-7) and a definition of what is represented by the rating (e.g., 0 = "Not assessed"). For the BPRS 1988 VERSION, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
The BPRS 1988 VERSION instrument includes a total score on the CRF that is considered as captured data on the CRF and is not considered as derived in the example below. This total score is considered as captured data when provided as part of Electronic Data Transfer (eDT) and is not considered as derived in the example below.
If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).
Terminology
RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
...
The table represents the items from the BPRS 1988 VERSION form instrument.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSLOBXFL | VISITNUM | RSDTC | | 1 | STUDYX | RS | P0001 | 1 | BPRS0101 | BPRS01-Somatic Concern | BPRS 1988 VERSION | Not assessed | 0 | 0 | Y | 1 | 2015-11-01 | | 2 | STUDYX | RS | P0001 | 2 | BPRS0102 | BPRS01-Anxiety | BPRS 1988 VERSION | Not present | 1 | 1 | Y | 1 | 2015-11-01 | | 3 | STUDYX | RS | P0001 | 3 | BPRS0103 | BPRS01-Emotional Withdrawal | BPRS 1988 VERSION | Very mild | 2 | 2 | Y | 1 | 2015-11-01 | | 4 | STUDYX | RS | P0001 | 4 | BPRS0104 | BPRS01-Conceptual Disorganization | BPRS 1988 VERSION | Mild | 3 | 3 | Y | 1 | 2015-11-01 | | 5 | STUDYX | RS | P0001 | 5 | BPRS0105 | BPRS01-Guilt Feelings | BPRS 1988 VERSION | Moderate | 4 | 4 | Y | 1 | 2015-11-01 | | 6 | STUDYX | RS | P0001 | 6 | BPRS0106 | BPRS01-Tension | BPRS 1988 VERSION | Moderately severe | 5 | 5 | Y | 1 | 2015-11-01 | | 7 | STUDYX | RS | P0001 | 7 | BPRS0107 | BPRS01-Mannerisms and Posturing | BPRS 1988 VERSION | Severe | 6 | 6 | Y | 1 | 2015-11-01 | | 8 | STUDYX | RS | P0001 | 8 | BPRS0108 | BPRS01-Grandiosity | BPRS 1988 VERSION | Extremely severe | 7 | 7 | Y | 1 | 2015-11-01 | | 9 | STUDYX | RS | P0001 | 9 | BPRS0109 | BPRS01-Depressive Mood | BPRS 1988 VERSION | Not present | 1 | 1 | Y | 1 | 2015-11-01 | | 10 | STUDYX | RS | P0001 | 10 | BPRS0110 | BPRS01-Hostility | BPRS 1988 VERSION | Very mild | 2 | 2 | Y | 1 | 2015-11-01 | | 11 | STUDYX | RS | P0001 | 11 | BPRS0111 | BPRS01-Suspiciousness | BPRS 1988 VERSION | Moderate | 4 | 4 | Y | 1 | 2015-11-01 | | 12 | STUDYX | RS | P0001 | 12 | BPRS0112 | BPRS01-Hallucinatory Behavior | BPRS 1988 VERSION | Moderately severe | 5 | 5 | Y | 1 | 2015-11-01 | | 13 | STUDYX | RS | P0001 | 13 | BPRS0113 | BPRS01-Motor Retardation | BPRS 1988 VERSION | Severe | 6 | 6 | Y | 1 | 2015-11-01 | | 14 | STUDYX | RS | P0001 | 14 | BPRS0114 | BPRS01-Uncooperativeness | BPRS 1988 VERSION | Extremely severe | 7 | 7 | Y | 1 | 2015-11-01 | | 15 | STUDYX | RS | P0001 | 15 | BPRS0115 | BPRS01-Unusual Thought Content | BPRS 1988 VERSION | Mild | 3 | 3 | Y | 1 | 2015-11-01 | | 16 | STUDYX | RS | P0001 | 16 | BPRS0116 | BPRS01-Blunted Affect | BPRS 1988 VERSION | Moderate | 4 | 4 | Y | 1 | 2015-11-01 | | 17 | STUDYX | RS | P0001 | 17 | BPRS0117 | BPRS01-Excitement | BPRS 1988 VERSION | Not present | 1 | 1 | Y | 1 | 2015-11-01 | | 18 | STUDYX | RS | P0001 | 18 | BPRS0118 | BPRS01-Disorientation | BPRS 1988 VERSION | Very mild | 2 | 2 | Y | 1 | 2015-11-01 | | 19 | STUDYX | RS | P0001 | 19 | BPRS0119 | BPRS01-Total Score | BPRS 1988 VERSION | 63 | 63 | 63 | Y | 1 | 2015-11-01 |
|
|
4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
...